Investigation of the Effect of Lipikar Baume AP+M

• ClinicalTrials.gov Identifier: NCT06385340
• Recruitment Status: Not yet recruiting
• First Posted: April 26, 2024
• Last Update Posted: April 26, 2024
• Sponsor: CentroDerm GmbH
• Information provided by (Responsible Party): CentroDerm GmbH

Tracking Information

• First Submitted Date: April 2, 2024
• First Posted Date: April 26, 2024
• Last Update Posted Date: April 26, 2024
• Estimated Study Start Date: April 23, 2024
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2024)

• Skin hydration measured by Corneometrie [ Time Frame: Day 28 ]
  Corneometer® (Courage + Khazaka electronics GmbH, Cologne, Germany) is used to assess skin hydration after 28 days. The Corneometer® measures in arbitrary units from 0 (no water) - 120 (on water). The units are referred to as "Corneometer® units". In total there will be 3 measurements at each point (Actinic keratosis, perilesional, never by actinic keratosis affected skin/healthy). The average of the 3 measurements is calculated and day 0 and day 28 are compared.
• Transepidermal water loss measured by Tewameter® [ Time Frame: Day 28 ]
  Transepidermal water loss (in g/m2/h - TEWL) measured by Tewameter® (Courage + Khazaka electronics GmbH, Cologne, Germany). 3 measurements at each arm und lesion will be taken (Actinic keratosis, perilesional and never by actinic keratosis affected skin). The average of the 3 measurements is calculated and day 0 and day 28 are compared.
• Aktinic keratosis area and severity index (AKASI) [ Time Frame: Day 28 ]
  The AKASI is a standardized tool for the clinically adequate assessment of larger areas (1). The area, distribution, erythema, and thickening of actinic keratoses are evaluated according to Dirschka et al. and a score is calculated. The score is between 0-18. Average values of study participants of each study group will be compared (day 0, day 28). 1. Dirschka T, Pellacani G, Micali G, Malvehy J, Stratigos AJ, Casari A, et al. A proposed scoring system for assessing the severity of actinic keratosis on the head: actinic keratosis area and severity index. J Eur Acad Dermatol Venereol. 2017;31(8):1295-302.
• S. aureus colonization and S. epidermidis colonization (application area) [ Time Frame: Day 28 ]
  S. aureus colonization and S. epidermidis colonization is assessed after 28 days by skin swabs and qPCR. Quantification is based on fluorescence measurements taken in real time during a PCR cycle. Fluorescence increases in proportion to the amount of PCR product. At the end of a run (consisting of several cycles), quantification is performed in the exponential phase of the PCR using the fluorescence signals obtained. Mean Ct values (cycle threshold) of the study groups are given for qPCR.
• Subjects's skin aspect [ Time Frame: Day 28 ]
  The investigator will assess the subject's skin aspect on the following signs or symptoms: scarring, atrophy, induration, redness or change in pigmentation. The Score is between 0 (poor) and 3 (Excellent). The investigator will assess the subjects skin aspect at day 28 for all lesions, that have disappeared. An anverage of the score is calculated for all lesions in each study group.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 22, 2024)

• Absolute lesion count by application site [ Time Frame: Day 28 ]
  Actinic keratoses that are clearly visible or palpably are counted at each study site (left and right arm and back of the hands). Absolute lesion counts by application site will be compared (day 0 and day28).
• Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site [ Time Frame: Day 28 ]
  The percentage of lesions with an improvement of at least one grade (Olsen grade) at day 28 will be assessed. For this the Olsen classification of each actinic keratosis should be recorded. This classification is based on a three-grade grading of the thickness of a single lesion and was first proposed by Olsen et al. Grade 1 describes a slightly palpable lesion, grade 2 a moderately thick and grade 3 a very thick and hyperkeratotic lesion. If actinic field cancerization is present, the highest Olsen grade in the area will be assessed. Average Olsen Scores by application site of Day 0 and D28 will be compared.
• Number of new lesions on application area over the study period by application site [ Time Frame: Day 28 ]
  All new actinic keratoses in the study area are recorded by application site (left and right arm and back of the hands). Day 0 and Day 28 will be compared concerning the average of new lesions by application site.
• Symptom severity score: percentage across individual scores at each visit by application site [ Time Frame: Day 28 ]
  A symptom score with a four-point Likert scale (absent, light, moderate, severe) is assessed as patient reported outcome (PRO). The symptom score includes four principal symptoms (itch, unpleasant burning, pain, tingling). The paper questionnaire with 4 questions will be handed out to the patient at Day 0 and Day 28. The symptom score is assessed for botch arms separately. The average scores by application will be compared concerning the overall score and the individual symptom scores (itch, burning etc.) at day 0 and day 28.
• modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9) [ Time Frame: Day 28 ]
  To assess the general satisfaction with Lipikar Baume AP+M an according to the study procedures modified TSQM-9 will be applied. This is a questionnaire that has been evaluated for the evaluation of antihypertensive medications but can also be applied to dermatological diseases. This includes nine questions with Likert-scaled answers to assess the satisfaction with the cosmetic. As the TSQM-9 was developped for medical agents, we changed the word medicament to "cosmetic", to assess the score at day 0 and day 28. The average of score of day 0 and day 28 will be compared.
• Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days) [ Time Frame: Day 28 ]
  A patient diary is used to assess the days on which Lipikar Baume AP+M was used. The proportion of patients with at least 75% of days and >90% of days on which Lipikar Baume AP+M was used will be calculated.
• Pictures at all time points [ Time Frame: Day 28 ]
  Pictures of the forearms and back of the hands are taken to illustrate the effects of Lipikar Baume AP+M.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of the Effect of Lipikar Baume AP+M
• Official Title: Investigation of the Effect of Lipikar Baume AP+M on Skin Barrier, Microbiome and AKASI of Participants With Actinic Keratoses and Field Cancerization of the Forearms and Hands

Brief Summary

Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.

It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.

A total of 20 subjects will be enrolled.

The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.

Masking: Single (Investigator)
Primary Purpose: Supportive Care

• Condition: Actinic Keratoses

Intervention

Other: Lipikar Baume AP+M

• Lipikar Baume AP+M Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme

Study Arms

• Lipikar Baume AP+M
  Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme
  Intervention: Other: Lipikar Baume AP+M
• No Intervention: no intervention
  Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 22, 2024): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2024
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male, female, diverse persons (> 18yo) who are capable of giving consent
• Female patients are eligible if the subject is not a woman of childbearing potential (WOCBP) or if she is postmenopausal (cessation of menstruation >12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, total hysterectomy)
• Signed informed consent
• Diagnosis of at least 4 actinic keratoses of the the forearm and/or back of the hand (each arm)
• Olsen grade I, II and/or III
• Subjects with similar severity and number of AKs on each side symmetrically
• The study participant is in good general condition for his or her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study

Exclusion Criteria:

• Known or documented intolerance to any of the ingredients of Lipikar Baume AP+M
• Any planned AK treatment during the study
• Treatment of actinic keratoses in the application area within the past 3 Months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
• Suspected invasive squamous cell cancer in the application area
• Chronic wounds, erosions, pre-existing infected skin or inflammation which, in the opinion of the investigator, are in need of treatment other than the study product
• Suspected non-compliance
• Current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil
• Any systemic immunosuppressant given within the 8 weeks prior to the study (e.g. systemic prednisolone, azathioprine etc.)
• Locally applied retinoids, steroids, or other prescribed externals in the 4 weeks prior to the start of the study that, in the opinion of the study physician, necessitate exclusion
• Products containing glycolic or alpha-hydroxy acids applied locally in the application area in the last 4 weeks
• Participation in another clinical trial
• Participation in a clinical study within the last 30 days
• Family members or colleagues of the investigator
• Participant is in a position or has a relationship with the investigator that presents a potential conflict of interest

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Thomas Dirschka, Prof. Dr.; 0202 - 62 933 70; info@centroderm.de

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06385340
• Other Study ID Numbers: CentroDerm_LRP22003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CentroDerm GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: CentroDerm GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Thomas Dirschka, Prof. Dr.; CentroDerm GmbH

• PRS Account: CentroDerm GmbH
• Verification Date: April 2024